"Mobile Stroke-Unit" for Reduction of the Response Time in Ischemic Stroke

NCT00792220 | Completed DMC

• 1 other identifier: MSU
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke, the most common cause of permanent disability, the second most common cause of dementia and third most common cause of death, has tremendous socio-economic consequences. Currently, systemic thrombolysis with the tissue plasminogen activator represents the only causal and approved treatment for acute ischemic stroke. However, the chances to save the brain tissue by a thrombolytic therapy exponentially decrease with proceeding time after onset of symptoms. In most cases, the beginning of the thrombolysis therapy is delayed by a variety of factors, like delivery to the hospital, re-examinations and delay of blood analysis or of CT scans. Due to this, a thrombolytic therapy is possible only in a minority of the stroke patients (2-5 %). The aim of this study is to investigate whether a "Mobile Stroke Unit", a rescue car with an integrated CT scanner, necessary for essential diagnostics, contributes to a better stroke management by saving precious time until a therapeutic decision is made. The trial is planned as a monocentric, randomised prospective trial.

Conditions

Stroke

Keywords

stroke; mobile stroke unit; thrombolysis; stroke management; computerized tomography

Outcome Measures

Primary Outcomes (1)

• Time between emergency call and therapy decision

Secondary Outcomes (1)

• Time between emergency call and end of CT, end of blood analysis, start of thrombolysis; time between symptoms and end of CT, end of blood analysis, therapy decision, number of patients with thrombolysis, start of thrombolysis, functional status

Study Arms (2)

MSU

EXPERIMENTAL

Procedure: MSU

OCCM

ACTIVE COMPARATOR

Procedure: OCCM

Interventions

MSU PROCEDURE

In the "Mobile Stroke Unit" procedure: Conventional Emergency Medical Service together with the MSU will meet at the side, where the patient is found. The MSU is an ambulance, equipped with a neurologist and neuroradiologist and includes CT scanner and point of care laboratory unit. The patient's medical history and the physical examination will be directly performed by the neurologist. CT scan analysis will be performed by the neuroradiologist, while the neurologist will analyze the blood samples with the point of care laboratory unit. If the inclusion and exclusion criteria are fulfilled, the thrombolytic therapy will directly be started by the neurologist. A possible thrombolytic therapy will be performed under the current inclusion and exclusion criteria that are associated with the rt-PA drug approval in Europe. After performance of the acute therapy, the patient will be transported to the University Hospital of the Saarland.

MSU

OCCM PROCEDURE

In the optimized conventional clinical management: After patient's medical history, physical examination and emergency treatment by the emergency physician, the patient will be transported to the University Hospital of the Saarland. The delivery of the patient will directly take place at the CT scanner. The neurologist will perform a second medical history, physical examination, while the blood will be drawn by the assisting nurse. CT scan will be performed, while the blood will be analyzed by point of care technique, placed close to the CT scanner. Additionally the blood will be sent in parallel to the hospital central laboratory for conventional laboratory analysis. Depending on the results, a thrombolytic therapy will be initiated directly at the CT. Thereafter, the patient will be transported to the hospital Stroke Unit.

OCCM

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 80 years
• Onset of symptoms until call at least 30 min prior to the end of the approved time window for thrombolysis (and not after awakening)
• Clinical signs of ischemic stroke with suddenly occurring, measurable neurological deficits defined as impairment of language, motor function, facial palsy or asymmetry
• Patient is willing to participate voluntarily and to sign a written informed consent. Informed consent will be obtained from each patient or the subject's legally authorized representative or relative.
• Patients who are unable to sign but who are able to understand the meaning of participation in the study may give an oral witnessed informed consent. These patients have to make undoubtfully clear that they are willing to participate voluntarily and must be able to understand an explanation of the contents of the information sheet.

You may not qualify if:

• Age younger than 18 or older than 80 years
• Non-acute onset of symptoms
• No focal stroke-like symptoms
• Pregnant patients

Sponsors & Collaborators

• University Hospital, Saarland: lead
• Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen: collaborator
• Meytec Information Systems GmbH, Werneuchen: collaborator
• Else Kröner Fresenius Foundation: collaborator
• Mercedes-Benz AG, Niederlassung Saarbrücken: collaborator
• Stadt Homburg: collaborator
• Rettungsstiftung Saarland: collaborator
• Rettungsdienst Logistik-Service GmbH, Saarland: collaborator

Study Sites (1)

Department of Neurology, University Hospital of the Saarland

Homburg/Saar, Saarland, 66424, Germany

Location

Related Publications (2)

• Fassbender K, Walter S, Liu Y, Muehlhauser F, Ragoschke A, Kuehl S, Mielke O. "Mobile stroke unit" for hyperacute stroke treatment. Stroke. 2003 Jun;34(6):e44. doi: 10.1161/01.STR.0000075573.22885.3B. Epub 2003 May 15. No abstract available.

  PMID: 12750527 BACKGROUND

• Walter S, Kostopoulos P, Haass A, Keller I, Lesmeister M, Schlechtriemen T, Roth C, Papanagiotou P, Grunwald I, Schumacher H, Helwig S, Viera J, Korner H, Alexandrou M, Yilmaz U, Ziegler K, Schmidt K, Dabew R, Kubulus D, Liu Y, Volk T, Kronfeld K, Ruckes C, Bertsch T, Reith W, Fassbender K. Diagnosis and treatment of patients with stroke in a mobile stroke unit versus in hospital: a randomised controlled trial. Lancet Neurol. 2012 May;11(5):397-404. doi: 10.1016/S1474-4422(12)70057-1. Epub 2012 Apr 11.

  PMID: 22497929 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Klaus C Fassbender, Prof. Dr.

  Neurology, University Hospital of the Saarland, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 13, 2008
• First Posted: November 17, 2008
• Study Start: November 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: June 2, 2015

Record last verified: 2015-05

Locations

DE (1)